Zileuton in Preventing Lung Cancer in Patients With Bronchial Dysplasia

NCT00056004 | Completed Phase 2 DMC

• 4 other identifiers: CDR0000271915P30CA022453WSU-D-2405WSU-093201MP4F
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of zileuton may be an effective way to prevent lung cancer in patients who have bronchial dysplasia. PURPOSE: Randomized phase II trial to study the effectiveness of zileuton in preventing lung cancer in patients who have bronchial dysplasia.

Conditions

Head and Neck Cancer; Lung Cancer

Keywords

non-small cell lung cancer; small cell lung cancer; stage I non-small cell lung cancer; stage I squamous cell carcinoma of the hypopharynx; stage I squamous cell carcinoma of the larynx; stage I squamous cell carcinoma of the lip and oral cavity; stage I squamous cell carcinoma of the nasopharynx; stage I squamous cell carcinoma of the oropharynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

• Bronchial dysplasia number and grade at 6 months

Secondary Outcomes (3)

• Biomarkers (Ki-67, Cyclin D1, bcl-2, bax, caspase-3) by immunohistochemistry at 6 and 12 months

• Biomarkers (5-HETE, LTB-4) by blood and BAL levels at 6 and 12 months

• Adverse events as measured by number and severity monthly

Interventions

zileuton DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * At high risk for dysplasia, defined by 1 of the following criteria: * Current or former smokers who have smoked at least 30 pack-years * Former smokers must be enrolled within 20 years of complete smoking cessation * Patients with curatively treated stage I non-small cell lung cancer\* * Patients with curatively treated stage I or II squamous cell carcinoma of the head and neck (limited to oral cavity, pharynx, or larynx)\* NOTE: \*At least 12 months post-curative therapy * Histologic confirmation of mild to severe bronchial dysplasia on bronchoscopic biopsy required * Moderate or severe atypia on sputum cytology required before bronchoscopy (not required for patients with prior lung or head and neck cancer) * No evidence of malignancy by chest x-ray PATIENT CHARACTERISTICS: Age * 18 and over (for patients with prior lung or head and neck malignancy) * 35 and over (for all other patients) Performance status * SWOG 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL * No bleeding disorder Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Liver enzymes no greater than ULN * PT/PTT no greater than ULN * No active or chronic liver disease (even if transaminases have normalized) Renal * Creatinine no greater than ULN Cardiovascular * No unstable angina * No uncontrolled heart failure Pulmonary * No significant asthma or chronic obstructive pulmonary disease requiring chronic or periodic (at least once per year) steroids for flares * No acute or chronic respiratory failure Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Willing and able to undergo serial bronchoscopic examinations * No ongoing alcohol use (i.e., at least 1 glass of wine, beer, or a mixed drink per day on a regular basis) * No other medical condition that would preclude safety during study participation * No other active or invasive malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No hypersensitivity to study drug or any of its inactive ingredients PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 3 months since prior corticosteroids\* * No concurrent corticosteroids\* * No concurrent anticancer hormonal agents NOTE: \*Systemic or inhaled, including chronic administration Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * More than 3 months since prior lipoxygenase inhibitors\* * More than 3 months since prior investigational agents * More than 3 months since prior nutritional supplements (except 1 daily multivitamin) * No concurrent nutritional supplements (except 1 daily multivitamin) * No other concurrent lipoxygenase inhibitors\* * No other concurrent investigational agents * No concurrent warfarin, beta-blockers, or theophylline * No other concurrent antineoplastic agents * No concurrent or chronic daily use of non-steroidal anti-inflammatory agents (NSAIDS) (except cardioprotective doses of aspirin less than 100 mg/day) * Periodic use of NSAIDS allowed * Concurrent participation in a smoking cessation program (including use of bupropion or nicotine gum or patch) allowed NOTE: \*Systemic or inhaled, including chronic administration

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Squamous Cell Carcinoma of Head and Neck

Interventions

zileuton

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Omer Kucuk, MD

  Barbara Ann Karmanos Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: June 1, 2003
• Primary Completion: September 1, 2006
• Study Completion: March 1, 2009
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)